BEUDAMED
    FDA Adverse Event Death Summary report: N

    VPAPIII ST - EUROPE

    MDR report key: 2884766 · Received December 11, 2012

    Report

    Report Number
    3004604967-2012-00054
    Event Type
    Death
    Date Received
    December 11, 2012
    Date of Event
    November 9, 2012
    Report Date
    December 12, 2012
    Manufacturer
    RESMED LTD.
    Product Code
    BZD
    PMA / PMN Number
    K030843
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY RESMED (B)(4) AND IS BEING RETURNED TO THE DESIGN FACILITY IN (B)(4) FOR AN ENGINEERING INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT A PT PASSED AWAY WHILE CONNECTED TO A VPAPIII DEVICE. AN OXYGEN DEPENDENT PT WITH A LONG HISTORY OF 'BREATHING PROBLEMS', HOSPITAL ADMISSIONS AND GRAVE PROGNOSIS WAS ADMITTED TO HOSPITAL ON (B)(6) 2012, FOR HAVING PROBLEMS WITH HIS OXYGEN EQUIPMENT. THE PT WAS DISCHARGED ON (B)(6) 2012 AND RETURNED HOME WITH HIS BREATHING EQUIPMENT. ON RETURNING HOME IT HAS BEEN ALLEGED THAT THE PT COMPLAINED OF PROBLEMS WITH THE BREATHING EQUIPMENT, THAT IT WAS BLOWING OUT TOO MUCH OXYGEN, BUT NO ONE WAS AVAILABLE TO LOOK AT THE EQUIPMENT. ON THE MORNING OF (B)(6) 2012, THE PT WAS FOUND NOT BREATHING AND THE AMBULANCE SERVICE WAS CALLED. IT HAS BEEN DESCRIBED THAT HE WAS FOUND WITH THE BREATHING MASK SLIGHTLY TO ONE SIDE OF HIS FACE. THE AMBULANCE STAFF ATTENDED TO THE PT, HOWEVER A SHORT TIME LATER, THE PT WAS PRONOUNCED 'LIFE EXTINCT'. THE ATTENDING POLICE OFFICERS WERE ALLEGEDLY TOLD BY THE FAMILY OF THE DECEASED THAT THE "BREATHING EQUIPMENT WAS A CAUSE OF DEATH".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VPAPIII ST - EUROPE BZD RESMED LTD. 24107

    Patients

    Seq Age Sex Outcome Treatment
    1 Death